Validation of Complex Cell-Based Potency Methods 2015

Acquire knowledge on complex cell-based methods, selection of the method and the cell line, and correlating the method with the pharmaceutical activity.

Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation. The areas covered in this presentation include:

Identification of pathways involved in activity
Selection of potency-indicating method(s)
Identifying the cell line
Selecting the assay platform
Method development
Creation of MCB and WCB
Consideration of orthogonal methods
FDA/EMEA/USP Guidelines
Selection and documentation of reference standard
Timeline for method validation
Annual updates